Arcanobacterium haemolyticum is known for causing pharyngitis in young adults and skin/soft tissue infections in older and immunocompromised people. We report here the case of a 25-year-old patient admitted to the emergency room for pain in the right iliac fossa. Abdominal computed tomography (CT) scan showed acute uncomplicated appendicitis. The biological assessment revealed an inflammatory syndrome with CRP at 124 mg/L. The patient underwent an appendectomy by laparotomy. The cytobacteriological analysis of deep pus revealed an important leukocyte reaction to neutrophils, and the growth of Arcanobacterium haemolyticum in culture. Antibiotic susceptibility testing showed that the bacterium was susceptible to clindamycin, tetracycline, linezolid, and rifampicin, and resistant to penicillin G, sulfamethoxazole/trimethoprim, moxifloxacin, ciprofloxacin, and vancomycin. Most studies have shown that this bacterium is susceptible to all classes of antibiotics except sulfamethoxazole-trimethoprim, however, in our case and like certain recent studies, other resistances are emerging.
{"title":"Acute appendicitis caused by Arcanobacterium haemolyticum","authors":"Ismail Faiz , Abderrazak Saddari , Said Ezrari , Samir Kaddouri , Elmostafa Benaissa , Yassine BenLahlou , Mostafa Elouennass , Adil Maleb","doi":"10.1016/j.clinmicnews.2024.12.001","DOIUrl":"10.1016/j.clinmicnews.2024.12.001","url":null,"abstract":"<div><div><em>Arcanobacterium haemolyticum</em> is known for causing pharyngitis in young adults and skin/soft tissue infections in older and immunocompromised people. We report here the case of a 25-year-old patient admitted to the emergency room for pain in the right iliac fossa. Abdominal computed tomography (CT) scan showed acute uncomplicated appendicitis. The biological assessment revealed an inflammatory syndrome with CRP at 124 mg/L. The patient underwent an appendectomy by laparotomy. The cytobacteriological analysis of deep pus revealed an important leukocyte reaction to neutrophils, and the growth of <em>Arcanobacterium haemolyticum</em> in culture. Antibiotic susceptibility testing showed that the bacterium was susceptible to clindamycin, tetracycline, linezolid, and rifampicin, and resistant to penicillin G, sulfamethoxazole/trimethoprim, moxifloxacin, ciprofloxacin, and vancomycin. Most studies have shown that this bacterium is susceptible to all classes of antibiotics except sulfamethoxazole-trimethoprim, however, in our case and like certain recent studies, other resistances are emerging.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"50 ","pages":"Pages 19-23"},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143095473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-28DOI: 10.1016/j.clinmicnews.2024.11.003
Maja Johanne Søndergaard Knudsen, Peder Worning, Sarah Juel Paulsen, Anne Line Engsbro
We report a fatal case of a comorbid male in his 70s admitted for erysipelas on the right lower leg. The condition developed rapidly and during debridement, the patient was diagnosed with necrotising fasciitis (NF). A. pittii was isolated from both blood and tissue samples. Despite broad-spectrum antibiotics, hyperbaric oxygen treatment and surgical intervention, the patient died from multiple organ failure. A review was conducted with a PubMed search for case reports/cohort studies with cases of Acinetobacter NF. Twenty-three articles were identified reporting on 30 cases with NF caused by Acinetobacter sp. (Acinetobacter baumanii 83 %, A. pittii 0). Infections were polymicrobial in 57 % of cases and fatal in 47 % of cases. For cases unrelated to war, most identified patients suffered from one or more comorbidities. A. pittii should be considered an important finding in a patient with a soft skin infection, and the risk of NF should be assessed.
{"title":"A fatal case of community-acquired Acinetobacter pittii necrotising fasciitis, and a review of the literature","authors":"Maja Johanne Søndergaard Knudsen, Peder Worning, Sarah Juel Paulsen, Anne Line Engsbro","doi":"10.1016/j.clinmicnews.2024.11.003","DOIUrl":"10.1016/j.clinmicnews.2024.11.003","url":null,"abstract":"<div><div>We report a fatal case of a comorbid male in his 70s admitted for erysipelas on the right lower leg. The condition developed rapidly and during debridement, the patient was diagnosed with necrotising fasciitis (NF). <em>A. pittii</em> was isolated from both blood and tissue samples. Despite broad-spectrum antibiotics, hyperbaric oxygen treatment and surgical intervention, the patient died from multiple organ failure. A review was conducted with a PubMed search for case reports/cohort studies with cases of <em>Acinetobacter</em> NF. Twenty-three articles were identified reporting on 30 cases with NF caused by <em>Acinetobacter</em> sp. (<em>Acinetobacter baumanii</em> 83 %, <em>A. pittii</em> 0). Infections were polymicrobial in 57 % of cases and fatal in 47 % of cases. For cases unrelated to war, most identified patients suffered from one or more comorbidities. <em>A. pittii</em> should be considered an important finding in a patient with a soft skin infection, and the risk of NF should be assessed.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"50 ","pages":"Pages 13-18"},"PeriodicalIF":0.0,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143095472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-22DOI: 10.1016/j.clinmicnews.2024.11.001
Reanay Berezovskiy , Meher Sultana , Jason Guyotte , Daria Yunina-Distefano , Niyati Goradia , Irene E. Rossmer
Peritoneal Tuberculosis (TB) is an uncommon manifestation of a mycobacterial infection, typically observed in immunocompromised individuals and/or those residing in endemic regions. Usually, patients will contract pulmonary TB, which results in dissemination or reactivation of latent infection months to years following the initial infection. Here, we present a case of peritoneal TB diagnosed in an immunocompetent patient devoid of recent travel history and with negative pulmonary findings. This case highlights the importance of considering peritoneal TB in the differential diagnosis, even in immunocompetent individuals with no apparent risk factors, highlighting the complexity and variability of TB presentations.
{"title":"Peritoneal Tuberculosis: Navigating diagnostic challenges","authors":"Reanay Berezovskiy , Meher Sultana , Jason Guyotte , Daria Yunina-Distefano , Niyati Goradia , Irene E. Rossmer","doi":"10.1016/j.clinmicnews.2024.11.001","DOIUrl":"10.1016/j.clinmicnews.2024.11.001","url":null,"abstract":"<div><div>Peritoneal Tuberculosis (TB) is an uncommon manifestation of a mycobacterial infection, typically observed in immunocompromised individuals and/or those residing in endemic regions. Usually, patients will contract pulmonary TB, which results in dissemination or reactivation of latent infection months to years following the initial infection. Here, we present a case of peritoneal TB diagnosed in an immunocompetent patient devoid of recent travel history and with negative pulmonary findings. This case highlights the importance of considering peritoneal TB in the differential diagnosis, even in immunocompetent individuals with no apparent risk factors, highlighting the complexity and variability of TB presentations.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"50 ","pages":"Pages 7-10"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143095470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-07DOI: 10.1016/j.clinmicnews.2024.10.004
Victoria Lobo-Antuña , Marta Lobo-Antuña , Juan Martínez-Andrés , Cristina Rodríguez-Prado , María Remedios Guna-Serrano , Atilio Navarro-Gonzales , Magdalena García-Rodríguez , Carmen Ricart-Olmos
Tuberculous otitis media is a rare form of extrapulmonary tuberculosis, often resulting in delayed diagnosis due to its nonspecific symptoms and low clinical suspicion. We present the case of a 29-year-old woman with initial symptoms of sudden speech impairment without other neurological manifestations. In the previous 3 months, the patient had consulted several times to the health care system due to bilateral otitis media, which did not improve with conventional treatments. Daily fever, diarrhea and weight loss were added to the picture. After admission to the Infectious Diseases department, she was diagnosed with advanced HIV infection and disseminated tuberculosis (TB) with pulmonary, intestinal, lymph node and otic involvement. This case underlines the complexity of diagnosing TB otitis media, especially in the context of HIV co-infection, and highlights the importance of routine HIV screening in patients with persistent, unexplained symptoms to facilitate early diagnosis and prevent complications.
{"title":"Bilateral otitis media as an initial manifestation of disseminated tuberculosis disease in a patient with late HIV infection diagnosis","authors":"Victoria Lobo-Antuña , Marta Lobo-Antuña , Juan Martínez-Andrés , Cristina Rodríguez-Prado , María Remedios Guna-Serrano , Atilio Navarro-Gonzales , Magdalena García-Rodríguez , Carmen Ricart-Olmos","doi":"10.1016/j.clinmicnews.2024.10.004","DOIUrl":"10.1016/j.clinmicnews.2024.10.004","url":null,"abstract":"<div><div>Tuberculous otitis media is a rare form of extrapulmonary tuberculosis, often resulting in delayed diagnosis due to its nonspecific symptoms and low clinical suspicion. We present the case of a 29-year-old woman with initial symptoms of sudden speech impairment without other neurological manifestations. In the previous 3 months, the patient had consulted several times to the health care system due to bilateral otitis media, which did not improve with conventional treatments. Daily fever, diarrhea and weight loss were added to the picture. After admission to the Infectious Diseases department, she was diagnosed with advanced HIV infection and disseminated tuberculosis (TB) with pulmonary, intestinal, lymph node and otic involvement. This case underlines the complexity of diagnosing TB otitis media, especially in the context of HIV co-infection, and highlights the importance of routine HIV screening in patients with persistent, unexplained symptoms to facilitate early diagnosis and prevent complications.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"50 ","pages":"Pages 1-6"},"PeriodicalIF":0.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142704208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-04DOI: 10.1016/j.clinmicnews.2024.10.003
Allison R. Eberly
Alphaviruses are arthropod-borne viruses (i.e. arboviruses) transmitted by mosquitos that are classically divided into two groups that infect humans: encephalitic and arthralgia-associated. While the encephalitic alphaviruses are primarily endemic in North and South America, alphaviruses associated with arthralgia are distributed globally. Given the overlapping clinical manifestations of alphaviruses with other arboviruses, diagnosis is dependent on both exposure history and laboratory testing. In the United States, diagnostic approaches largely rely on detection of host antibodies against these viruses via enzyme-linked immunosorbent assays (ELISAs) or indirect immunofluorescence assays (IFAs) in serum and/or cerebrospinal fluid. Positive results can be confirmed by plaque reduction neutralization testing (PRNT), which remains the reference standard method for anti-alphavirus antibody detection. Increasingly, select public health and reference laboratories are also offering molecular testing for certain alphaviruses, including chikungunya virus and Eastern equine encephalitis virus. Molecular testing, however, is most useful in acutely ill, viremic patients who present within the first week of symptom onset. There are no targeted antivirals for treatment, and prevention relies on protection from mosquito bites.
{"title":"Medically important alphaviruses in the United States and how to test for them","authors":"Allison R. Eberly","doi":"10.1016/j.clinmicnews.2024.10.003","DOIUrl":"10.1016/j.clinmicnews.2024.10.003","url":null,"abstract":"<div><div>Alphaviruses are arthropod-borne viruses (i.e. arboviruses) transmitted by mosquitos that are classically divided into two groups that infect humans: encephalitic and arthralgia-associated. While the encephalitic alphaviruses are primarily endemic in North and South America, alphaviruses associated with arthralgia are distributed globally. Given the overlapping clinical manifestations of alphaviruses with other arboviruses, diagnosis is dependent on both exposure history and laboratory testing. In the United States, diagnostic approaches largely rely on detection of host antibodies against these viruses via enzyme-linked immunosorbent assays (ELISAs) or indirect immunofluorescence assays (IFAs) in serum and/or cerebrospinal fluid. Positive results can be confirmed by plaque reduction neutralization testing (PRNT), which remains the reference standard method for anti-alphavirus antibody detection. Increasingly, select public health and reference laboratories are also offering molecular testing for certain alphaviruses, including chikungunya virus and Eastern equine encephalitis virus. Molecular testing, however, is most useful in acutely ill, viremic patients who present within the first week of symptom onset. There are no targeted antivirals for treatment, and prevention relies on protection from mosquito bites.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"49 ","pages":"Pages 28-36"},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142701833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Scabies is a common skin condition, cause by the mite known as Sarcoptes Scabiei. Every year, 150–200 million people worldwide suffer from scabies. Small children are most vulnerable to scabies, which is most prevalent in congested, unsanitary living environments. It can transfer both directly from person to person and indirectly through contact with contaminated things. Scabies results in a highly irritating host immunological reaction. Impetigo and other secondary bacterial skin infections might result from scratching the wounds. It was officially classified as a neglected tropical illness by the World Health Organization in 2017. This review gives an overview of all the available therapy to treat scabies, and recent advancements in the management of scabies treatment in preclinical as well as clinical trials.
{"title":"Current scenario and future prospect of scabies treatment: A comprehensive review","authors":"Nishan Hazra , Soutik Sarkar , Srijita Chakrabarti","doi":"10.1016/j.clinmicnews.2024.10.002","DOIUrl":"10.1016/j.clinmicnews.2024.10.002","url":null,"abstract":"<div><div>Scabies is a common skin condition, cause by the mite known as <em>Sarcoptes Scabiei</em>. Every year, 150–200 million people worldwide suffer from scabies. Small children are most vulnerable to scabies, which is most prevalent in congested, unsanitary living environments. It can transfer both directly from person to person and indirectly through contact with contaminated things. Scabies results in a highly irritating host immunological reaction. Impetigo and other secondary bacterial skin infections might result from scratching the wounds. It was officially classified as a neglected tropical illness by the World Health Organization in 2017. This review gives an overview of all the available therapy to treat scabies, and recent advancements in the management of scabies treatment in preclinical as well as clinical trials.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"49 ","pages":"Pages 15-27"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142534343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-10DOI: 10.1016/j.clinmicnews.2024.10.001
Christopher George Kendra , Kevin Andrew Smith , Trina Trusty , Amber Ryan , Kenneth Gavina
Loa loa is an arthropod-transmitted filarial nematode, and one of four pathologically prevalent blood microfilaria associated with human infection. This case report describes an instance of a 41-year-old male diagnosed with Loa loa by peripheral blood smear and subsequently also diagnosed with Onchocerca. Here we describe the clinical course, diagnostic evaluation and treatment considerations when managing potential nematode co-infections. This case also highlights laboratory diagnosis strategies, treatment challenges, and emphasizes a differential diagnosis of chronic infections with neglected tropical infectious agents.
Loa loa 是一种节肢动物传播的丝虫,也是与人类感染有关的四种病理流行血液微丝蚴之一。本病例报告描述了一名 41 岁男性通过外周血涂片被诊断为 Loa loa,随后又被诊断为盘尾丝虫的病例。在此,我们描述了临床过程、诊断评估和治疗潜在线虫合并感染时的注意事项。本病例还强调了实验室诊断策略和治疗挑战,并强调了被忽视的热带传染病慢性感染的鉴别诊断。
{"title":"“Eye see worms on the down Loa”: A case study of microfilarial co-infection","authors":"Christopher George Kendra , Kevin Andrew Smith , Trina Trusty , Amber Ryan , Kenneth Gavina","doi":"10.1016/j.clinmicnews.2024.10.001","DOIUrl":"10.1016/j.clinmicnews.2024.10.001","url":null,"abstract":"<div><div><em>Loa loa</em> is an arthropod-transmitted filarial nematode, and one of four pathologically prevalent blood microfilaria associated with human infection. This case report describes an instance of a 41-year-old male diagnosed with <em>Loa loa</em> by peripheral blood smear and subsequently also diagnosed with <em>Onchocerca</em>. Here we describe the clinical course, diagnostic evaluation and treatment considerations when managing potential nematode co-infections. This case also highlights laboratory diagnosis strategies, treatment challenges, and emphasizes a differential diagnosis of chronic infections with neglected tropical infectious agents.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"49 ","pages":"Pages 10-14"},"PeriodicalIF":0.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142534344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-24DOI: 10.1016/j.clinmicnews.2024.09.002
Oluwabunmi Bola Olajide , Joshua Seun Olajide , Olusanya Olasehinde
Dengue is the leading arboviral disease of major public health importance across the globe. Severe dengue causes bleeding and shock, and can be life threatening, terminating in death. There has been considerable success in vector territorial mapping, disease transmission process, diagnosis and molecular characterization of the virus. However, continuous sporadic outbreaks and re-emergence of dengue infections are common in recent time. Also, limited treatment options, weak host immune response in sequential infection, inadequate preventive measures in some areas and continual territorial expansion of the vectors are factors sustaining dengue transmission. In this review, we present an overview of dengue virus, disease predisposing factors, surveillance tools and control measures. In addition, we offer suggestions on future research direction to deepen the control efforts. Nonetheless, continual re-emergence of dengue requires redirection from antibody-dependent enhancement and the use of insecticides into environmentally favourable bio-control and molecular surveillance of the vector until effective vaccines are readily available.
{"title":"General perspectives on dengue fever","authors":"Oluwabunmi Bola Olajide , Joshua Seun Olajide , Olusanya Olasehinde","doi":"10.1016/j.clinmicnews.2024.09.002","DOIUrl":"10.1016/j.clinmicnews.2024.09.002","url":null,"abstract":"<div><div>Dengue is the leading arboviral disease of major public health importance across the globe. Severe dengue causes bleeding and shock, and can be life threatening, terminating in death. There has been considerable success in vector territorial mapping, disease transmission process, diagnosis and molecular characterization of the virus. However, continuous sporadic outbreaks and re-emergence of dengue infections are common in recent time. Also, limited treatment options, weak host immune response in sequential infection, inadequate preventive measures in some areas and continual territorial expansion of the vectors are factors sustaining dengue transmission. In this review, we present an overview of dengue virus, disease predisposing factors, surveillance tools and control measures. In addition, we offer suggestions on future research direction to deepen the control efforts. Nonetheless, continual re-emergence of dengue requires redirection from antibody-dependent enhancement and the use of insecticides into environmentally favourable bio-control and molecular surveillance of the vector until effective vaccines are readily available.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"49 ","pages":"Pages 1-9"},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142426161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1016/j.clinmicnews.2024.09.001
Rob E. Carpenter
On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency's long-standing policy of enforcement discretion. This paper offers a concise historical overview and examines the FDA's revised regulatory framework scheduled for the next four years, examining its impact on laboratory operations in terms of safety, efficacy, and innovation. It explores how the new rule's increased compliance demands and economic implications impact laboratory operations, including economic stability, innovation, and patient safety. Also highlighted is how certain laboratories gain strategic advantages that could enhance their market stability and attract investors. The overall intent of this paper is not an in-depth analysis but instead it aims to inform stakeholders in health services about evolving laboratory standards. By doing so, it equips healthcare participants to strategically align with emerging regulatory demands, enhancing comprehension of how these changes influence healthcare delivery and laboratory procedures.
{"title":"Navigating the new norm: The FDA's final rule on laboratory developed tests (LDTs) and its impact on clinical laboratory operations","authors":"Rob E. Carpenter","doi":"10.1016/j.clinmicnews.2024.09.001","DOIUrl":"10.1016/j.clinmicnews.2024.09.001","url":null,"abstract":"<div><div>On April 29, 2024, the U.S. Food and Drug Administration (FDA) issued a transformative final rule impacting the regulatory landscape for laboratory-developed tests (LDTs). This new regulation categorizes in vitro diagnostics (IVDs) used as LDTs under the same stringent oversight applied to other medical devices, thereby phasing out the agency's long-standing policy of enforcement discretion. This paper offers a concise historical overview and examines the FDA's revised regulatory framework scheduled for the next four years, examining its impact on laboratory operations in terms of safety, efficacy, and innovation. It explores how the new rule's increased compliance demands and economic implications impact laboratory operations, including economic stability, innovation, and patient safety. Also highlighted is how certain laboratories gain strategic advantages that could enhance their market stability and attract investors. The overall intent of this paper is not an in-depth analysis but instead it aims to inform stakeholders in health services about evolving laboratory standards. By doing so, it equips healthcare participants to strategically align with emerging regulatory demands, enhancing comprehension of how these changes influence healthcare delivery and laboratory procedures.</div></div>","PeriodicalId":39211,"journal":{"name":"Clinical Microbiology Newsletter","volume":"48 ","pages":"Pages 1-8"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}